K242666

Substantially Equivalent

Fecobionics Anorectal System

Applicant: Gi Bionics, LLC
Product code: KLA
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-05
Decision date: 2025-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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